LITHO DK30

Powered Laser Surgical Instrument

QUANTA SYSTEM, S.P.A.

The following data is part of a premarket notification filed by Quanta System, S.p.a. with the FDA for Litho Dk30.

Pre-market Notification Details

Device IDK141403
510k NumberK141403
Device Name:LITHO DK30
ClassificationPowered Laser Surgical Instrument
Applicant QUANTA SYSTEM, S.P.A. VIA IV NOVEMBRE,116 Solbiate Olona,  IT 21058
ContactMaurizio Bianchi
CorrespondentMaurizio Bianchi
QUANTA SYSTEM, S.P.A. VIA IV NOVEMBRE,116 Solbiate Olona,  IT 21058
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-28
Decision Date2014-08-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08033945936938 K141403 000

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